System And Method For Valve Control

ABSTRACT

Disclosed is a system including a flow control assembly. The system may include a flow regulating shunt system, for various purposes. The flow control assembly may be controlled according to selected parameters and methods.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application includes subject matter similar to that disclosed inconcurrently filed U.S. patent application Ser. No. ______ (AttorneyDocket No. 5074PS-000055). The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The subject disclosure relates to a valve assembly, and particularly toa valve assembly and method therefore.

BACKGROUND

This section provides background information related to the presentdisclosure which is not necessarily prior art.

A system may be used to treat a selected or various conditions of asubject. The subject, for example a human subject, may be treated forhydrocephalous. Hydrocephalous may be caused due to an overproduction,under absorption, or blockage of outflow of cerebral spinal fluid (CSF)from a ventricle in a brain of a subject. Hydrocephalous, therefore, maycause various conditions in the subject. It may be desirable to treatthe hydrocephalous with a shunt system to allow for drainage of the CSFfrom the ventricle to a different area of the subject to treat oralleviate the undesired conditions of the subject.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

A shunt system may be implanted into a subject as a therapy forhydrocephalous. The shunt system may include an inlet and an outlet toshunt or direct fluid away from a first area to a second area of thesubject. In various embodiments, an inlet catheter may be implanted intoa ventricle of the subject and an outlet catheter may be positioned in adistal area, such as a peritoneum and/or vasculature of the subject. Theshunt system may further include a flow control system.

The flow control system may include a valve assembly. The valve assemblymay have an opening or cracking pressure that will allow fluid to flowthrough the valve system at a selected pressure. The valve system mayinclude a valve seat and selected mechanism to select or control acracking pressure of the valve body.

The flow control assembly may include various portions, such asmicroelectromechanical systems (MEMS) to operate on the valve body andseat. The MEMS system may be controlled by various control portions inthe flow control assembly. The flow control assembly, therefore, may bea valve assembly that is mechanically operated with the MEMS system.

Further, the control system may include one or more processors and aselected memory that may operate or control the MEMS system.Accordingly, the valve flow control may be controllable, such asautonomously or semi-autonomously, controlled. Further, one or morefeedback loops, which may be opened or a closed feedback loop, may beused to assist in controlling the valve assembly. Therefore, the flowcontrol assembly may include one or more valve portions that may be usedto control the valve assembly for operation of a shunt system.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a schematic environmental view of a shunt and systempositioned in a subject, according to various embodiments;

FIG. 2 is an exploded diagrammatic view of a valve assembly, accordingto various embodiments;

FIG. 3 is a cross-sectional view taken along lines 3-3 of FIG. 2;

FIG. 4 is a detailed view of an actuator, according to variousembodiments;

FIG. 5A is a top plan view of a support assembly;

FIG. 5B is a cross-section taken along lines 5B-5B of FIG. 5A;

FIG. 6 is a schematic illustration of a valve assembly, according tovarious embodiments; and

FIG. 7 is a flow chart of an operation of a valve assembly, according tovarious embodiments.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

FIG. 1 includes an illustration of a fluid directing or shunt system 10.The shunt system 10 may be positioned or implanted within a subject 14,such as a human subject. The shunt system 10 may shunt or direct a fluidto flow along the shunt system 10, such as in the direction of arrow 18.The shunt system 10 may include a catheter 20, which may be an inletcatheter, positioned within a ventricle 24 in the subject 14. As isgenerally understood by one skilled in the art, the inlet catheter 20may be positioned (i.e. implanted) in the ventricle 24 to allow thefluid to be drained away from the ventricle 24. The shunt system 10 mayfurther include a selected flow control system 28 and an outlet catheter32.

The selected flow control system 28 may be implanted in the subject 14in an appropriate position. In various embodiments, the selected flowcontrol system 28 may be implanted generally near a skull 36 of thesubject 14, a torso 38 of the subject 14, or any other appropriatelocation. It is understood that the inlet catheter 20 may be connectedto the selected flow control system 28 as is the outlet catheter 32.

The outlet catheter 32 may extend from the selected flow control system28 to a selected location, such as a peritoneal cavity in the torso 38of the subject 14. The inlet catheter 20, the selected flow controlsystem 28, and the outlet catheter 32 may generally be understood to bea shunt system 10. The shunt system 10 may be useful as a hydrocephalusshunt system. The shunt system 10 may be entirely implanted in thesubject 14.

The fluid may flow in the direction of arrow 18 into and through theinlet catheter 20, through the selected flow control system 28, andthrough the outlet catheter 32. The fluid may then drain or pass throughthe outlet catheter 32 into the peritoneal cavity, or any otherappropriate location, of the subject 14. The fluid may be cerebralspinal fluid (CSF) that is produced in the ventricle 24. The shuntsystem 10 may be implanted to assist in treating hydrocephalus in thesubject 14. It is understood that the outlet catheter 32 may bepositioned within the subject 14 in an appropriate location to allow fordraining of the CSF from the ventricle 24 to an appropriate location,such as one with high blood flow. Accordingly, as illustrated in FIG. 3,the inlet catheter 20, the selected flow control system 28, and theoutlet catheter 32 may be implanted or positioned in the subject 14 as aCSF shunt system.

As discussed above, the shunt assembly 10 may include the flow controlassembly 28. In various embodiments, the flow control assembly mayinclude a valve assembly 50. With reference to FIGS. 2 and 3, the valveassembly 50 is illustrated. The valve assembly 50 may be incorporatedinto the flow control assembly 28, including with other portionstherein, such as inlet and outlet coverings, filters, and the like, ormay be included as the only portion of the flow control assembly 28.Accordingly, the valve assembly 50 may be understood to be the flowcontrol assembly or system 28, as discussed above, or at least a portionthereof.

The valve assembly 50, therefore, may be provided as the flow controlassembly 28 for controlling a flow through the shunt assembly 10according to various embodiments. The valve assembly 50 may include theportions discussed further herein, and may be operated, as alsodiscussed herein, in various embodiments.

The valve assembly 50 may generally include various portions, such as afirst valve body or enclosure 54, that may also be referred to as a cap.The valve body 54 may include the cap or other removable portionrelative to additional portions, such as a base or lower enclosure orbody portion 58. The valve cap 54 may include one or more portions, suchas a valve seat or seal area 62 that forms or defines a seal surface 64.The seal surface 64 may be engaged by a sealing member, such as a ball68. The ball or sealing member 68 may include an external surface 72that is formed to mate with the sealing surface or ring 64. The valveassembly 50, therefore, may seal the sealing member 68 into the sealingsurface 64 to stop a flow through the valve assembly 50.

The valve assembly 50 may include the inlet 20 that engages or seals toan inlet portion or area 76 at the sealing area 62. The inlet 20, asdiscussed above, may allow a fluid to generally flow in the direction ofarrow 18 from the ventricle 24 into the inlet area 76 of the valveassembly 50. When the valve member 68 is not sealed into the sealingsurface 64, fluid may flow through and past the valve sealing area 62through a valve volume 78 and out an outlet 82. The valve volume 78 is areservoir volume of the valve assembly 50. The outlet 82 may beintegrally formed and/or connected to the outlet catheter 32, such thatthe fluid may flow generally in the direction of arrow 18 through theoutlet catheter 32, as discussed above. Accordingly, the valve assembly50 may allow for flow of the CSF through the valve volume 78 and/or stopflow by sealing the sealing member 68 onto the sealing surface 64, asdiscussed above and further herein.

The valve assembly 50 may include the valve body 54 and/or valve bodyportions 54, 58 into a sealed configuration such that the internalvolume 78 of the valve assembly 50 allows for a control of flow throughthe valve assembly 50. The valve assembly may further adjust or change apressure of the sealing member 68 against the sealing surface 64. Invarious embodiments, therefore, the sealing member 68 may be biasedgenerally in the direction of an arrow 86 into the sealing surface 64. Apressure applied through the inlet area or volume 76 may generally be ina direction of an arrow 88 opposite the arrow 86. The sealing member 68may be removed or moved away from the sealing surface 64 to allow theflow through the outlet 82. As discussed further herein, the biasingpressure or the sealing pressure or force generally in the direction ofarrow 86 may be adjusted and/or selected based upon various factors andparameters to select an opening or cracking pressure to allow the CFS toflow through the valve assembly 50, generally in the direction of arrow18.

The valve assembly 50 further includes a power source 94, which mayinclude one or more batteries. The power source 94 may store power foroperating or powering a control assembly or portion 98. The controlassembly 98 may include various portions, such as those discussedfurther herein, for controlling or manipulating the sealing member 68relative to the sealing portion or ring 64. In various embodiments, thecontrol assembly 98 may be sealed relative to the valve volume 68 by asealing assembly or internal sealing assembly 102. The sealing assembly102 may include various portions such as an outer or an external sealingring or member 106 that may seat or seal against a wall 110 having anupper surface 114 that may seal against a lower surface 118 of thecontrol assembly portion 98. The internal sealing portion 102 mayfurther include a sealing membrane 126 that may span an area within thesealing member or portion 106. The sealing portion 106 may furtherinclude an upper surface 128 that may seal against an inner or lowersurface 134 of the valve body or cap 54. Thus, the valve volume 78 maybe sealed from the control assembly 98 and/or the battery 94. The valveassembly 50 may operate or include electronic components in the controlassembly 98 regardless of the material that flows through the valvevolume 78.

The control assembly portion 98, as discussed above, may include a sealor engaging wall 114. The sealing wall 114 may extend from a selectedassembly or surface, such as a printed circuit board (PCB) including aglass PCB 140. The PCB 140 may include a selected component and/orinclude or encapsulate selected components such as a coil or antennaassembly 144. The antenna assembly 144 may be used for various purposes,such as communication with an external controller or programmer 148(FIG. 1). Further, the antenna assembly 144 may be used to assist inrecharging (e.g. inductive charging) the power source 94 such as with anear filed charging assembly end or inductive assembly. Thus, theantenna 144 may be used for communication with a selected component,such as the programmer 148 and/or for recharging the power source 94.

The antenna assembly 144 may be used for communication with the controlassembly 98 and/or between with the controller or programmer 148. Thecontrol assembly 98 may include various components that may be used tostore and/or execute instructions. The control assembly 98, for example,may include various components for operation of the valve assembly 50 tocontrol a flow through the shunt assembly 10.

For example, the control assembly 98 may include a processing unit ormodule 150 may communicate with a selected assembly, such as amicroelectromechanical system (MEMS) 154 to control various componentsthereon for operation of the valve assembly 50. The controls may operateto move the sealing member 68 into the sealing ring 64. The controlassembly 98 may further include a memory portion, such as included withthe processor 150 and/or separate from the processor 150. In addition,the control assembly 98 may include various components such as a signalgenerator 158 that may generate a signal, such as the transmission withthe antenna 144. Further the control assembly or components 98 mayinclude a capacitor and/or other electronic component 162 and anoscillator assembly 166.

The various components of the control assembly 98 may be provided foroperation or assembly of the valve assembly 50, as discussed furtherherein. Generally, the control assembly 98 may include one or moreprocessor systems that may receive feedback and/or instructions forselecting or providing a cracking or opening pressure of the sealingmember 68 from the sealing ring 64. Accordingly, the processor 150 maybe provided to execute selected instructions in various otherappropriate or selected electronic components may be provided to operatethe valve assembly 50. Accordingly, the above and herein describedcomponents may be exemplary and alternative and/or additional componentsmay be provided to operate the valve assembly 50.

According to various embodiments, the MEMS 154 may include one or morecomponents to selectively control the valve assembly 50 such as byapplying a biasing pressure or force generally in the direction of arrow86 of the sealing member 68 onto the sealing ring 64. With continuingreference to FIGS. 2 and 3, and additional reference to FIG. 4, the MEMSassembly 154 may include one or more actuators 180 formed on a substrate184. The substrate 184 and the actuators 180 may be formed in anyappropriate manner, such as those generally known in the art. Suchactuators and manufacturing techniques may include actuators such asthose produced or developed by Sandia National Labs. Other examplesinclude sensors that can also act as actuators such as MEMs microphonesincluding the MP34DT05 and MP34DT06J microphones sold bySTMicroelectronics.

The actuators 180 may be actuated at least between two positions, suchas a flat or substantially planar position and a raised or engagedpositions, as illustrated in FIG. 4 and FIG. 5B. In the raised position,the actuator may include an engaging or contacting surface or portion190 that may engage a cantilever or supporting member 194. The valveassembly 50 may include a selected number of cantilever members 194,such as four cantilever 194 formed in a cruciform, as illustrated inFIG. 2. The cantilevers 194 may be individually identified as 194 a, 194b, 194 c, and 194 d. The supports 194 may be connected, such ascantilevered, at one end to the sealing member 106. The sealing member106 may be further supported in the valve assembly 50, while the arms194 extend therefrom to interact with a valve support or support member198 that is configured to support or hold the sealing member 68. Thevalve support 198 and/or the valve member 68 may otherwise beunsupported within the valve assembly 50. The flexible assembly 126 mayprovide some support, but the arms 194 may also assist in supporting theflexible assembly 126. It is understood, however, that the arms 194 neednot be cantilevered from the sealing member 106 and may otherwise besupported from the substrate 184, the control assembly wall 110, orother appropriate position.

In various embodiments, therefore, each of the cantilever portions 194may be engaged by one or more of the actuators 180, such as with thecontacting portion 190. Each of the actuators, as discussed above andherein, may also be individually identified by a lowercase letter a, b,c, or d. Therefore, the selected actuator may engage the selectedsupport arm 194 to apply a pressure to the valve support or supportmember 198 that supports or holds the sealing member 68 and/or directlyto the sealing member 68.

The support member 198 may support the sealing member 60 in a selectedposition relative to the sealing ring 64. The support member 198 mayinclude an external wall 202 that forms or defines an internal surface206 that may be complimentary or near the shape of the sealing member68. As the sealing surface 64 may also compliment or engage the sealingmember 68 the support member 198 may also engage the sealing member 68to seal the passage or volume 78 relative to the flow of the fluidthough the valve assembly 50. Accordingly, the support member 198 mayengage and hold the sealing member 60 at a selected position and apply aforce generally in the direction of the arrow 86 to select or control aflow of the fluid through the valve assembly 50.

The cantilever arms 194 may extend from the sealing ring or wall 106toward the support member 198. Accordingly, the cantilever arms 194 mayhold or support the support member 198 relative to the sealing wall 106and/or the control assembly wall 110. As illustrated in FIG. 3, thevalve assembly 50 including the control assembly 98 and the sealingassembly 102 may engage or seal the sealing member 68 within the valveassembly 50 and the various control components of the control assembly98, as discussed above.

Further, extending between the cantilever arms 194 may be the sealing orflexible assembly 126. The flexible assembly 126 may seal the valvevolume 78 from the control components 98, as discussed above. Further,the flexible portion 126 may move with the cantilever arms 194 tomaintain the seal of the volume 78 relative to the electronic components98 and other portions of the valve assembly, such as relative to theexternal sealing ring or wall 106.

In various embodiments, for example, the actuators 180 may move thecantilever arms 194 generally in the direction of arrow 86. In otherwords, the actuator members 180 may move the sealing member 68 to engagewith the sealing surface 64. In various other embodiments, however, thesealing member 68 may be assembled into the valve assembly 50 such thatthe sealing member contacts the sealing surface 64. The actuators 180may apply a force to increase a biasing force of the sealing member 68onto the sealing surfaces 64 such as a force generally in the directionof the opening direction 88 needs to be increased above or greater thanthe force created by the cantilever arms 194. Accordingly, the actuators180 may be operated or moved into an actuated or contacting position tochange or alter an opening pressure or force on the valve assembly, suchas to move the sealing member 68 generally in the direction of arrow 88to open the valve assembly 50. Accordingly, the actuators 180 mayoperate to move the sealing member 68 into the sealing surface 64 and/orincrease the biasing force generally in the direction of arrow 86 toadjust an opening or cracking pressure of the valve assembly 50.

As illustrated in the Figures, the actuators 180, therefore, maygenerally be moved or operated to move in the direction of arrow 86and/or in the direction of arrow 88 by a selected electromechanicalsystem, including portions generally understood by those skilled in theart. For example, a power or driving portion 220 may be formed or placedon the electronics component 98. The driving component 220 may beinterconnected with various linkages, such as a first linkage 224 to oneor more gears or gear assemblies 228. The gear assemblies 228 may rotatewhen powered by the driver 220. The gear assembly 228 may transfer,increase or decrease a power ratio, or change the direction of a motorfor force. The motor force may move a drive or pushing arm 232 that maybe held or moved relative to a rail or rail assembly 236.

The drive arm 232 may be hingedly connected by one or more hinges 240 toa first member or support member 244 of the actuator 180. The firstsupport member 244 may be hingedly connected by a second hinge portionor assembly 248 to a second support member 252. The two support members244, 252 may interact to form the actuator 180, as discussed furtherherein. The second support member 252 may also be hingedly connected bya third hinge portion or assembly 256 to the substrate 184.

As is generally understood by one skilled in the art, the actuatorassembly 180 may be formed on the substrate 184 in any appropriatemanner. For example, a MEMS system or machine, such as the actuator 180,may be formed by selected appropriate techniques such as etching (e.g.wet or dry etching), electrical discharge machining (EDM), molding,plating, and the like. As is generally understood by one skilled in theart the various manufacturing techniques may be used to form the variouscomponents of the MEMS system, such as the actuator 180. The actuator180 may then be incorporated into other components and/or with othercomponents, such as with the processor 150 for operation according toselected techniques and/or instructions.

With continuing reference to FIGS. 3 and 4, and additional reference toFIGS. 5A and 5B, the actuator 180 may be operated, such as according toinstructions executed by the processor 150, to engage one or more of thecantilever or support arms 194. The actuators 180 may be moved to theactuated or engaging position, as illustrated in FIG. 4. In the engagedposition, the engaging portion 190 may engage or contact the support orcantilever arm 194. As illustrated in FIG. 4, according to variousembodiments, the engaging portion 190 may be supported by the secondengaging or supporting member 252 relative to or against the firstsupporting 244. The first supporting member 244 may be moved to pushagainst, and therefore cause, the second support member 252 to movegenerally in a vertical direction, such as away from the substrate 184generally in the direction of arrow 86. Upon movement or in the engagingposition, the actuator 180 may engage the cantilever arm 194.

With reference to FIG. 5A and FIG. 5B, the substrate 184 may bepositioned relative to or near the support structure or portion 102. Invarious embodiments, for example, the two support cantilever members 194a, 194 c may extend from the outer or extend the wall 106 toward thevalve support member 198. The support members 194 a, 194 c may generallybe formed to be substantially rigid and support the support member 198at a selected distance from the external wall 106. Generally, thesupport arms 194 a, 194 c, or any of the support arms 194 may besubstantially the same length 260 from the internal wall 106 to thesupport member 198, and/or to a center of the support member 198.

When the sealing member 68 is positioned in the support member 198 andengages the sealing surface 64, an incoming force, such as generally inthe direction of arrow 88, may deflect or move the sealing member 68away from the sealing surface 64 by deflecting or moving the supportmembers 194 also generally in the direction of arrow 88. Therefore, theforce applied by the support members 194 may be overcome by an incomingforce, such as a hydraulic force caused by an inflow of fluid. Further,the opening force may be set by the distance 260, form or material ofthe support members 194, or other appropriate features. For example, asize, thickness, rigidity, material selection, or the like may be madeto set or select an initial force required to move the sealing member 68away from the sealing surface 64.

During operation of the flow control valve assembly 50, however, theactuators 180 may be selectively operated to engage the support members194. In various embodiments, a plurality of the actuators may beprovided. In various embodiments, for example, three actuators may bepositioned between or in the distance 260. For example, as illustratedin FIG. 5A between the substrate 184 and the support member 194 a may bethree of the actuators 1801, 1802, and 1803. Further, between thesubstrate 184 and the support member 194 c may be three additionalactuators 1804, 1805, and 1806. During operation, any one or more of theactuators 180 may be actuated to contact the respective supports 194.Further, in the various manufacturing techniques, each of the actuatorsmay be individually and separately operated or actuated to contact thesupports 194. It is understood that the supports 194 b and 194 d alsoinclude respective actuators 180, which are not discussed specificallyhere but are understood to operate in a generally similar manner.

During operation of the valve assembly 50, for example, the outermost orfirst actuators for both of the support arms 194 a, 194 c may beoperated. Accordingly, the actuator 1801 and 1806 may be operated toextend from the substrate 184 and contact the respective support members194 a, 194 c. As illustrated in FIG. 4, the actuator 180 may extend fromthe substrate and the contact area 190 may contact the supports 194.Accordingly, the supports 194 may be further stiffened or have thedistance 260 effectively shortened, such as to a distance 260′. Bystiffening the support member 194, and/or further supporting the supportmember 194 relative to the substrate 184, the force required in thedirection of arrow 88 to move or unseat the sealing member 68 from thesealing surface 64 may be increased. The amount of force may begenerally known and calibrated relative to or per the distance 260and/or the distance 260′, the selected number of the actuators 180actuated to engage the respective support members 194, or otherappropriate mechanisms. Accordingly actuation of the actuators 180 maybe made to contact the support members 194 and increase the openingpressure of the valve assembly 50.

According to various embodiments, for example, the valve assembly 50 maybe operated to select an opening pressure or force to unseal the sealingmember 68. Selected feedback may be provided to select an openingpressure. The opening pressure may be selected or set. Further theopening pressure or force may be based upon a selected or measured inputpressure.

As discussed above, the various actuators 180, according to variousembodiments and exemplary illustrated as the actuators that may beformed as an “A” frame subassembly are illustrated. These actuators maycontact the support members 194 to generate or allow the sealing member68 to remain seated in or against the sealing surface 64 and/or moveaway from the sealing surface 64.

The valve assembly 50, as illustrated in FIG. 2 and FIG. 3, may furtherinclude a pressure sensor assembly 290. The pressure sensor 290 may beincorporated into the support member 198 such as include with thesupport member 198 to engage or sensor a pressure on the support member198. The pressure sensor 290 may also be another appropriate portion. Invarious embodiments, the pressure sensor 290 may include or incorporatethe sealing membrane 126 and/or the supports 194. For example, thepressure sensor 290 may be any appropriate pressure sensor such as apiezo-resistive pressure sensor and the sealing portion or member 126may act as a component thereof. Appropriate piezo-resistive pressuresensors include pressure transducers, such as those sold by KoninklijkePhilips N.V., having a pace of business USA, including and/or similar tothe pressure sensor included in the CPJ84022 pressure transducerassembly sold by Koninklijke Philips N.V. Other examples include theMPX5010/MPXV5010G/MP3V5010 series sensors sold by NXP Semiconductors.The pressure sensors 290 may sense a pressure of the sealing member 68against the valve seal 198. The pressure sensed with the pressure sensor290 may be based upon an incoming pressure such as through the inlet 20.Accordingly, the pressure through the inlet 20 may be based upon thepressure of the CFS flowing into the inlet 20 and/or into the valveassembly 50. The pressure sensor 290 may transmit a signal to theprocessor 150 in an appropriate manner, such as with a wired connection(e.g. a trace through the support assembly 102 to the electronicsassembly 98), wirelessly, or combinations thereof. The signal may bemeasured over time and may, therefore, be measured as an absoluteinstantaneous pressure, a change in pressure, or other appropriatedetermination of pressure sensed at the pressure sensor 290.

The valve assembly 50 may be operated based upon the signal from thepressure sensor 290. For example, a selected threshold change inpressure, a selected measured absolute or instantaneous pressure, or anyother appropriate pressure determination may be used to operate thevalve assembly 50. As discussed further herein, for example, at aselected instantaneous pressure (e.g. a pressure above a selectedthreshold) a certain number of the actuators 180 may be relaxed or madeinactive to allow for a flow of the CSF more easily (such as by loweringthe opening force) though the valve assembly 50. Further, at a selectedinstantaneous pressure (e.g. at a pressure below a selected threshold) aselected number of the actuators 180 may be operated to increase anopening pressure required to move the sealing member 68 from the sealingsurface 64. Thus, a selected volume or pressure of CSF may be maintainedwithin the ventricle 24 of the subject 14 according to selectedparameters, such as those identified and programmed by a user, such aswith the programmer 148.

As discussed above, the valve assembly 50 can include variouscomponents, including those as situated and discussed above. Withcontinuing reference to the above figures, and further reference to FIG.6, the valve assembly 50 may include various components that mayoperate, as discussed further herein. Generally, the valve assembly 50may include the processor or control assembly 150. As discussed above,the processor module or control module may be used to evaluate variousinputs to control operation of components of the valve assembly 50. Theinputs may also be various inputs such as sensor inputs or externalinputs.

In various embodiments, the programmer 148 may be operated by a user,such as a clinician or a surgeon, to select a set point or selectedvalue for one or more parameters of or relative to the valve assembly50. In various embodiments, the set point may be a pressure set point,such as a pressure experience at or on the valve member at the inlet,sealing area, or seat 62. The selected set point may be one or morediscrete pressure set points that may be selected directly and/or from alist by the user. As discussed above, the programmer 148 may includevarious inputs or input portions such as buttons or a touch screen 149and/or a display 151. The user may therefore provide various inputsand/or selections with the programmer 148.

The selections by the user from the programmer 148 may then betransmitted to the controller 150, as illustrated in FIG. 6. Thetransmission may be in any appropriate manner such as a wirelesstransmission, wired transmission, or other type of transmission. Asdiscussed above, the valve assembly 50 may include one or more portions,such as the antenna 144. Accordingly the programmer 148 may wirelesslytransmit a signal to the controller 150 through the antenna 144.Regardless the programmer 148 may be used to determine or select a setpoint, such as a pressure set point for the valve assembly 50. It isunderstood that other appropriate inputs may be provided to thecontroller 150 to select or determine a set point, such as a pressureset point.

As discussed above, the valve assembly 50 may include the pressuresensor 290 that may be incorporated or positioned in selected portionsof the valve assembly 50, such as within or near the reservoir 78. Thepressure sensor 290 may measure a pressure within the reservoir 78 orother selected portion of the valve assembly 50. The pressure sensor maythen transmit a signal to the controller 150. As discussed above thesignal may be transmitted wirelessly and/or via the electronicscomponent of the valve assembly 50. Nevertheless, the pressure sensor290 may measure or sense a pressure and transmit a selected signalrelated to the measured pressure to the controller 150.

The controller 150 may further include an integrator which may beincluded in the processor module, to integrate or compare the set pointinput to a measured pressure input. The controller 150 may thenintegrate or compare the received measured pressure input to the setpoint pressure input. Based upon the comparison, the controller 150 maythen determine to change or alter a configuration of the valve assembly50. As discussed above, the valve assembly 50 may be operated toincrease or decrease a cracking or opening pressure of the valvecomponents to increase a flow or decrease a flow through the valveassembly. Accordingly, the controller may, if determined based upon acomparison, transmit a signal, also referred to as an actuator signal,to the actuators 180.

The actuators 180, upon receiving a selected signal from the controller150, may then either activate or deactivate (e.g. move to an inactiveposition), or remain the in the same position. As discussed above, theactuators 180 may activate or raise (i.e. FIG. 4) to change or increasea cracking or opening pressure of the valve assembly 50. When raised,the actuator contacts the support arm 194. The actuators 180 maydeactivate or lower to decrease an opening or cracking pressure of thevalve assembly 50. When lowered the actuator contacts the support arm194. Accordingly, the actuators 180 may operate or move based upon asignal from the controller 150 in light of the measured or sensedpressure from the pressure sensor 290.

The valve components, such as the valve member 68, the sealing areas 64,and/or the ball or valve support 198, may then be altered or effected bythe actuators 180, as discussed above. The actuators 180 may increase ordecrease an effective length of the supports 194 to change the force(e.g. biasing) on the valve seat 198. Thus, the valve may change itsconfiguration and opening pressure for operation of the valve assembly50.

The valve assembly 50, according to various embodiments, may include thecomponents as illustrated in FIG. 6, to effect a therapy for the subject14. A user may select a pressure set point, such as via the programmer148, which is transmitted to the controller 150. The controller 150 maythen receive the input from the set point and measure or sense pressurefrom the pressure sensor 290 for operation of the valve assembly 50.

In various embodiments, the set points may include a selected number ofdiscrete pressure settings, such as about 20 discrete pressure settingsat set or selected intervals between about 20 millimeters (mm) of water(about 0.02 pounds per square inch (PSI)) to about 400 mm of water(about 0.6 PSI). In various embodiments, for example, the discretepressure settings may be at about 20 mm of water between 20 mm of waterand 400 mm of water. The user may select from a selected number ofdiscrete settings with the programmer 148 that may be displayed on thedisplay 150. It is further understood, however, that selected set pointsmay be made by the user that may be then transmitted to the controller150 for operation and control of the valve assembly 50.

With continuing reference to FIG. 6 and additional reference to FIG. 7,a method or operation of the valve assembly 50 is illustrated in theflow chart 300. The method 300 may begin at start block 310. The startblock 310 may include appropriate steps or portions, such as initiatingoperation of the valve assembly 50. It is understood that the startblock 310 may further include and/or follow other operations such asdiagnosis of the subject 14, determination of a selected therapy,implantation of the valve assembly 50, selection of various features, orthe like. Nevertheless, the process 300 may begin in start block 310.After the start 310, the valve assembly 50, such as the controller 150,may receive an input. As discussed above, the programmer 148 or otherappropriate portion may be used to select and transmit a signal to thevalve assembly 50. The programmer 148 may be operated by a selected userto transmit an input or signal to the valve assembly 50.

The received input in block 320 may be any appropriate inputs such as apressure input set point. As discussed above, the user may select one ormore pressure set points and these may be received by the controller150. Other appropriate inputs may also include a flow rate that may beachieved or selected through the valve assembly 50. Further, a specificactuator configuration may also be determined. As discussed above, theactuators 180 may be used to select or achieve a selected distance 260of the support 194. The specific configuration may be determined by theuser and provided as an input that may be received by the controller150. Nevertheless, as discussed above, the input may be a pressure setpoint and the controller 150 may select the actuators 180 to activatebased upon a predetermined configuration (e.g. a factory calibration).Nevertheless, the input may be received in block 320 at the controller150. In various embodiments, the input may also include a start or stopcommand for the valve assembly 50.

The received input at the controller 150 may be used in combination witha sensed or measured parameter in block 330. For example, the sensed ormeasured parameter in block 330 may relate to or be regarding thereceived input from block 320. For example, as discussed above, thepressure sensor 290 may sense a pressure in the reservoir 78, such as atthe valve member 68, of the valve assembly 50. The parameter measuredmay also include a flow rate, or other appropriate measurement. Invarious embodiments, such as those discussed further herein, includemeasuring a pressure in block 330 with the pressure sensor 290. Thesensed or measured pressure may then be transmitted with a signal fromthe pressure sensor 290 in block 340. The signal may be transmitted tothe controller 150 for comparison to the received input in block 350.

As discussed above, the controller 150 may include various components,such as an integrator, processor module, or the like for comparison ofthe received input to the transmitted signal. In various embodiments thereceived input may include a pressure set point from the programmer 148.The pressure set point may then be compared to the signal from thepressure sensor transmitted in block 340 and compared in block 350. Thesignal may include a selected signal, such as an analog or digitalsignal that may be compared to the received input from block 320. Theappropriate comparison, may be any appropriate comparison, to allow fora determination of whether the valve assembly 50 is operating at theselected set point. Accordingly, a decision may then be made by thecontroller 150 of whether the transmitted signal matches the receivedset point in block 360.

The decision block 360 may be made based upon the comparison block 350.Accordingly, the selected user may transmit a set point in block 320which may be compared in block 350 to a measured parameter in block 330.

If the decision block 360 determines that the transmitted signal matchesthe received input a YES path 370 may be followed. The YES path 370 maybe returning to either receiving the input in block 320 and/or sensing ameasured parameter in block 330. In various embodiments, therefore, themethod 300 may be a loop process where the parameter is continuallymeasured in block 320 and compared in block 350. The decision block 360may be then used to determine whether the operation of the valveassembly 50 needs to be altered. A periodic check, such as over aselected period of time, including every hour, every 24 hours, or thelike may be made to determine whether the controller 150 has received anadditional input from the user in block 320. Accordingly, a selectedadditional or new input from the user to the controller 150 may alter orchange the operation of the method 300. For example, the user maydetermine to stop operation of the valve assembly 50, such as formaintenance, removal, or the like.

If the decision block 350 determines that the transmitted signal fromblock 340 does not match the received input from block 320, a NO path380 may be followed. The NO path 380 may include transmission of asignal to activate or deactivate actuators in optional block 390. Theactuators, as discussed above, may alter the valve assembly in block400. The actuators 180 may alter or change various valve components,such as the sealing portion or member 126, the support 190, or the like.The transmission of a signal to activate or deactivate actuators inblock 390 may be one selected operation of the valve assembly 50 toalter or change the valve assembly 50 to attempt to achieve the selectedset point or input from the user in block 320. Accordingly, when the NOpath 380 is followed, altering the valve assembly in block 400 may beperformed. Appropriate alterations may include activating ordeactivating one or more of the actuators, such as by transmission ofthe signal in block 390.

After altering the valve assembly in block 400, a continuation ofsensing or measuring a parameter in block 330 may be followed, asdiscussed above when following the YES path 370. Again, a periodic orselected check of an input from the user in block 320 may also be made,such as over a selected or set period of time.

Accordingly, the valve assembly 50 may be operated according to themethod 300 for controlling the pressure and/or flow rate through thevalve assembly 50. The valve assembly 50 may receive a signal, such asat the controller 150. The signal may be from the user, such as throughthe programmer 148, to control or select an operation of the valveassembly 50. The selection may include selection of a pressure setpoint, as discussed above. The method 300, therefore, may be used tooperate or control the valve assembly 50, such as with the controller150.

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail.

In one or more examples, the described techniques may be implemented inhardware, software, firmware, or any combination thereof. If implementedin software, the functions may be stored as one or more instructions orcode on a computer-readable medium and executed by a hardware-basedprocessing unit. Computer-readable media may include non-transitorycomputer-readable media, which corresponds to a tangible medium such asdata storage media (e.g., RAM, ROM, EEPROM, flash memory, or any othermedium that can be used to store desired program code in the form ofinstructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processors, such as one ormore digital signal processors (DSPs), general purpose microprocessors,graphic processing units (GPUs), application specific integratedcircuits (ASICs), field programmable logic arrays (FPGAs), or otherequivalent integrated or discrete logic circuitry. Accordingly, the term“processor” as used herein may refer to any of the foregoing structureor any other physical structure suitable for implementation of thedescribed techniques. Also, the techniques could be fully implemented inone or more circuits or logic elements.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

What is claimed is:
 1. A method of operating a flow and/or pressureregulating assembly for a hydrocephalus shunt system, the methodcomprising: biasing a valve member in a closed position relative to avalve seat with an arm support member; sensing a parameter relative tothe valve member; and operating an actuator formed from and on asubstrate near the arm support member to be positioned in an activeposition or an inactive position relative to the arm support member toeffect a biasing force applied to the valve member.
 2. The method ofclaim 1, further comprising: selecting an effective support length ofthe arm support member to determine the biasing force on the valvemember.
 3. The method of claim 2, further comprising: executinginstructions with a controller to compare a sensed pressure applied toan inlet side of the valve member to determine the position of theactuator.
 4. The method of claim 3, wherein operating the actuator inthe active position includes decreasing a support length of the armsupport member to increase the biasing force.
 5. The method of claim 3,wherein operating the actuator in the inactive position includesincreasing or maximizing a support length of the arm support member todecrease the biasing force.
 6. The method of claim 1, furthercomprising: selecting a set point for the parameter; comparing the setpoint of the parameter to the sensed parameter; and selecting a positionof the actuator based on the comparison.
 7. The method of claim 6,wherein the parameter is an inlet pressure.
 8. The method of claim 7,further comprising: receiving the selected set point; and storing theset point.
 9. The method of claim 7, further comprising: executinginstructions with a controller to perform the comparison; transmittingan actuation signal to operate the actuator in the active position todecrease a support length of the arm support member to increase thebiasing force when the sensed parameter is less than the set point. 10.The method of claim 7, further comprising: executing instructions with acontroller to perform the comparison; transmitting an actuation signalto operate the actuator in the inactive position to increase a supportlength of the arm support member to decrease the biasing force when thesensed parameter is greater than the set point.
 11. The method of claim1, further comprising: receiving a set point value for the parameter.12. The method of claim 11, further comprising: operating a controllerto execute instructions to compare the sensed parameter and the receivedset point value.
 13. The method of claim 12, wherein operating theactuator includes at least one of (i) changing the actuator from theactive position to the inactive position, (ii) changing the actuatorfrom the inactive position to the active position, or (iii) maintainingthe actuator in a current active position or a current inactiveposition.
 14. The method of claim 12, wherein operating the actuatorincludes forming a biasing force on the valve member based on thecomparison.
 15. The method of claim 1, wherein operating the actuatorincludes operating a plurality of actuators.
 16. A method of operating aflow and/or pressure regulating assembly for a hydrocephalus shuntsystem, the method comprising: providing a reservoir having a reservoirinlet and a reservoir outlet; providing a valve member supportedrelative to a valve seat to regulate flow into the reservoir through thereservoir inlet; and configuring an actuator in response to an actuatorsignal from a controller to move the actuator between an activateposition and an inactivate position; wherein the actuator is selectivelypositioned in the active position or the inactive position to select abiasing force on the valve member for regulating the flow into thereservoir.
 17. The method of claim 16, further comprising: providing anantenna to wirelessly receive a set point parameter value; providing acontroller to compare the set point value parameter to a measure valueparameter at the valve member.
 18. The method of claim 17, furthercomprising: transmitting a signal based on the comparison to configurethe actuator.
 19. The method of claim 18, wherein the transmitted signalis to increase the biasing force when the measured value is less thanthe set point parameter value.
 20. The method of claim 18, whereinconfiguring the actuator includes moving the actuator to the activeposition.
 21. The method of claim 20, wherein configuring the actuatorincludes moving the actuator to the inactive position.
 22. The method ofclaim 18, wherein the transmitted signal is to decrease the biasingforce when the measured value is greater than the set point parametervalue.
 23. A method of operating a flow and/or pressure regulatingassembly for a hydrocephalus shunt system, the method comprising:implanting the regulating assembly; selecting a set point value for aparameter; operating a sensor to cense a parameter value relative to avalve member; and operating a controller to: compare the set point ofthe parameter to the sensed parameter; select a position of the actuatorbased on the comparison; operate the actuator in an active position oran inactive position relative to the valve member to effect a biasingforce applied to the valve member.
 24. The method of claim 23, furthercomprising: transmitting the selected set point to the controller. 25.The method of claim 23, further comprising: altering a support armlength by the operation of the actuator to effect the basing force.